To DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendment filed 04/13/2026 has been entered. Applicant’s amendments are in response to in the Non-Final Office Action mailed 11/13/2025. Applicant’s claims have been amended in the following manner: independent claims 31 and 32 have been substantially modified (the clause of “that regulates…” is supported in the Specification [0068-0070]), and furthermore, the claim set format overall has been modified, in response to the previous Office Action. Furthermore, new claims 41-52 have been entered. Thus, a new ground of rejection is applied, prompted by the collective changes from this amendment.
The species election of midodrine salt is maintained (see restriction requirement from 05/09/2025), which is found to read on all claims except for claim 34 (directed to dipyridamole or rivastigmine) and new claim 43 (direct to topiramate).
Newly submitted claim 43 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claim 43 is not directed to the elected species of midodrine salt.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 43 withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Furthermore, edits are made to previous language to better clarify the teachings of the Art, with respect to the BRI of the claim language, as plainly stated.
The following objections/rejections are withdrawn: claim objections for claim 1 and 31 (due to claim 1 cancellation and removal of “use”); 112b rejection (due to cancellation of claim 24 and removal of “hair modulator”); 112d rejection (due to cancellation of claim 33).
The Examiner further acknowledges the following:
Claims 31-32, 34-36 and 38-52 are pending.
Claim 34 and 43 is withdrawn from consideration as directed to non-elected inventions.
Claims 31-32, 35-36, 38-42, and 44-52 are presented for examination and rejected as set forth below.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 31-32, 35-36, 38-42, 44-45, 47, and 49-52 are rejected under 35 U.S.C. 103 as being unpatentable over Goren (WO2020023084A1; published 1/30/2020, compared to the priority date of 06/26/2020).
Applicant’s claim 31 (see also similar independent claim 32, that narrows the focus on midodrine) are directed to a method of hair follicle modulation comprising topically administering a bioactive agent to hair follicles on skin of a mammal that regulates activity of genes and/or proteins in cells of the hair follicles and changing hair phenotype as hair fiber is actively produced at bulbs of the hair follicles and grows out of the skin, wherein,… when hair follicle modulation comprises hair straightening, the bioactive agent comprises midodrine or midodrine salt;… Note that focus is turned to “midodrine salt” due the previously made species election (i.e., the other “bioactive agents” of the claim scope are not considered), and that the claims are generally framed by the transitional term “comprising”.
Additionally note, as a point of definition distinction from a PHOSITA, when Applicant amends in the term “hair follicle”, the “hair follicle” (i.e., the shaft or opening on the surface of the skin through which hair grows) is considered different from the “hair fiber” (i.e., the keratin-based material that grows from hair follicles, that may or may not have been intended by Applicant) (see Applicant’s Specification [0007], for distinction between hair fiber and hair follicle). Furthermore, the Examiner accepts “prevention” of defective production of melanin (instant claim 52), as enabled, as melanin defects can be caused by UV light, and there are pathways to support the outcome of preventing it.
Applicant has elected midodrine salt, as the elected species, for which the rejection will be focused on. The Examiner recognizes midodrine to be involved in hair modulation such as straightening in Table 2 (pg 31) of the Specification.
Goren teaches bioactive agents for hair loss (abstract) by contracting the arrector pili muscle to prevent hair plucking under stress [0013]. Goren teaches formulations in the form of styling products [0046] and a method of applying (Goren – claim 8).
Regarding claim 31-32 and 39-42: Goren teaches a method of applying midodrine compositions (Goren – claims 8 and 14, [0056]) (where salts of other active agents are demonstrated as suitable for topical application and effect, and thus, salts are taught as obvious variations of free based active agents, see [0057, 0058]) which is topically applied to the scalp or hair follicle (Goren – claim 1, [0013]) in formulations for the skin including “at least one hair follicle” (i.e., also reads on application to the hair follicle, because a PHOSITA would understand that it would be impossible to apply a composition to the scalp skin surface only without additional application to the surrounding hair follicle and/or fibers) (Goren – claim1, [0036, 0039, 0046]) to prevent hair loss (abstract) with direction toward human scalp and hair [0033, 00129-00130], Goren – claims 67-69). Furthermore, Goren teaches a method of flat ironing hair before, during, and/or after applying the composition (Goren – claim 43 and 44).
Note also that midodrine can be used in combination with ethacrynic acid, dipyridamole, rivastigmine, paroxetine, etc. in the disclosure of Goren [0049]; thus, the method of topical application of these agents to human scalp and hair is obvious.
Furthermore, the Examiner additionally points to the section of Goren that includes all salt forms of the active agent agonists [0089], including the alpha adrenergic receptor agonists, such as midodrine [0049, 0084], in response to Applicant’s arguments against Goren’s teaching of “midodrine salt”.
Regarding claims 35, 44-45, 47, and 50-52: Goren teaches the bioactive agent in 0.1-35 wt% [0051] (thus, within the claimed range and encompassing the amount demonstrated in the Specification of Table 2 on pg 31), thickeners [0053], preservatives such as EDTA or sodium metabisulfite (in 0.1-0.5 wt%) [0053], alcohols/glycols [0053], fatty acids [0053], and excipients [0053].
Regarding claims 36 and 38: Goren teaches prolonged release systems by encapsulation[0045], and makes mention of liposomes [0070].
Regarding claim 49: Goren teaches many formulations such as creams, gels, foams, conditioners, etc. [0046].
Thus, the instant method claimed appears to be little more than the selection of art-known elements according to their known utility within a single prior art reference, teaching the desirability of selecting such components, and obvious thereby, that the composition of the instant invention is obvious. It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.).
Further note, that because Goren teaches midodrine salt and the claimed amount applied to the scalp, the discovery of a method to apply topical midodrine to style hair is merely the discovery of an unappreciated property of the prior art method: "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). To sum up, since an ingredient and its properties are inseparable, midodrine is inherently a hair shape-modifying (or straightening) compound, and subjects that use Goren’s method with Goren’s amount of midodrine would find favorable hair styling properties, as a result of the method of midodrine application, as taught by Goren. Thus, application of midodrine is expected to allow for hair shaping (e.g., as claimed by claim 31, etc.), as in the method disclosure of Goren.
Further note, that Goren teaches flat ironing the hair (i.e., reads on straightening, whereby a hair can be shaped with either a straight or curled structure by flat iron) after application of compositions comprising midodrine to the scalp (Goren – claim 43 and 44), whereby application of the composition to the scalp is considered to also cause application to hair follicles and/or fibers, because a PHOSITA would understand that it would be impossible to separate application of a composition to the scalp skin surface, without also affecting the hair follicles and/or hair fibers present on the scalp.
Claims 31-32, 35-36, 38-42, and 44-52 are rejected under 35 U.S.C. 103 as being unpatentable over Goren (WO2020023084A1; published 1/30/2020), as applied to claims 31-32, 35-36, 38-42, and 44-45, 47, and 49-52 and in further view of Hermann (US20100080761A1).
In summary, Goren teaches the elements of the instant method for topical application of a midodrine salt composition to the scalp/hair, except for specific thickeners such as xanthan gum (instant claim 46), and specific alcohols such as glycerin (instant claim 48).
Hermann teaches a composition and method of modifying human hair growth and skin/hair pigmentation (abstract), where formulations can also be in the shape of styling products (Hermann – claim 20).
Herman teaches thickeners [0082] such as xanthan gum [0273], alcohols such as glycerol (also called glycerin) [0197-0198], tanning agents [0080-0081] for self-tanning (Hermann – claim 19) in a topical formulation for hair (abstract, Hermann – claims 11-12)), whereby browning/tanning and/or lightening of skin/hair is desirable [0004].
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of applying a topical midodrine formulation of Goren by adding the thickeners, alcohols, and tanning agents of Hermann to the formulation because tanning is desirable in the field of cosmetics [0004] and thickeners/alcohols are ingredients typical of topical cosmetic formulations (where Goren teaches coloring agents [0044], carriers for the formulation [0070] and thickeners [0053]). The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Because Goren and Hermann are both directed to preventing hair loss and in the form of styling products, it would be obvious to incorporate the specific ingredients taught by Hermann into Goren’s formulations.
Response to Arguments
Applicants arguments, see pg 8-13 filed 04/13/2026, with respect to the 103 rejection of claims 1, 3-6, 22-26, 31-33, 35-36, and 38-40 under rejection have been fully considered but they are not persuasive. The 103 rejection has been modified with respect to amendments made to the claim set and new added claims. A new ground of rejection is thus applied prompted by the claim amendments.
On page 8-9, Applicant discusses amendments that address the claim objections and 112 rejections. The changes made are acceptable (based on removal of affected claims and terms, as previously discussed in the ‘response to amendments section’ above).
On page 9-11, Applicant argues that the instant invention operates by a different mechanism compared to Goren (i.e., Goren targets “hair fibers out of the skin or the scalp” or “hair dead fiber” and/or “goosebump” effects, and therefore does not affect changes in ‘newly produced’ hair volume or color). Applicant explains that this is encompassed by the new limitation (i.e., “that regulates activity of genes and/or proteins in cells of the hair follicles and changing hair phenotype as hair fiber is actively produced at bulbs of the hair follicles and grows out of the skin”). Applicant then provides a reproduction of data from table 2 from pg 31 of the Specification (reposted below) to support this new limitation.
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Applicant concludes that the demonstrated method outcomes (i.e.., the Examiner considers only the hair straightening by “midodrine salt”, which is the instant elected species) cannot be considered disclosed or inherent to the teachings of Goren, because Goren does not teach the mechanism(s) described by Applicant. Thus, the Applicant claims surprising results demonstrated by applying the above compositions (i.e., especially the elected species of midodrine), that result in the demonstrated hair shape changes.
This line of argumentation with respect to “midodrine salt” is not persuasive. Because Goren teaches compositions comprising midodrine salt and the instantly claimed amount applied to the scalp (e.g., Goren teaches the obviousness of a applying a 0.25 wt% midodrine salt composition, as exemplified in the instant Table 2 above) followed by flat ironing, the discovery of a method to apply topical midodrine to style/straighten hair (i.e., including the limitation of “regulates activity of genes and/or proteins in cells of the hair follicles and changing hair phenotype as hair fiber is actively produced at bulbs of the hair follicles and grows out of the skin”, which is a complex way of describing the mechanism of said hair styling and/or straightening) only describes the expected result of Goren’s method. Thus, the hair straightening properties would necessarily flow from the topical application of midodrine salt compositions described by Goren, owing to the fact that the active agent and method steps suggested by the art and recited in the present claims are the same, and subjects that use Goren’s method with Goren’s amount of midodrine would find favorable hair styling/straightening properties, as a result of the method of midodrine application, as taught by Goren. Applicant has not provided objective evidence that Goren’s compositions would not be capable of straightening hair in contrast to the instant Application. Thus, application of midodrine is expected to provide the same beneficial effect that Applicant claims for their disclosure.
Furthermore, with respect to the argument that Goren targets “hair fibers out of the skin or the scalp” or “hair dead fiber”, and therefore does not affect changes in ‘newly produced’ hair volume or color, note that Goren’s method applies the midodrine salt composition over the scalp (i.e., “skin on the head that includes at least one hair follicle”) (Goren - claim 1), which contains all hair structures that are involved in ‘newly produced’ hair (see image of hair cross section below). Furthermore, Applicant has already admitted to Goren’s process inducing “goosebumping” which only happens when skin is stimulated.
Additionally, Goren teaches flat ironing the hair (i.e., whereby a hair can be shaped with either a straight or curled structure by flat iron, as evidenced by That’s Foxy (2015) (pg 3)) after application of compositions comprising midodrine to the scalp (Goren – claim 43 and 44), such that the favorable styling properties of the composition is expected. Furthermore, Goren’s method of applying the composition to the scalp would also cause application to hair follicles and/or fibers, because a PHOSITA would understand that it would be impossible to separate application of a composition to the scalp skin surface (Goren – claim 1), without also affecting the hair follicles and/or hair fibers present on the scalp (see image of hair cross section below).
On pg 10, Applicant argues that Goren is explicitly directed to traction-based alopecia. Note the broadness in which the method claims of Goren are written (Goren – claim 1), such that there is no specific target patient population in Goren’s claim 1, whereby the only requirement is that the composition is “applied topically to a portion of skin on the head that includes at least one hair follicle” (Goren – claim 1). Thus, the specific embodiments of Goren discussed by Applicant (i.e., with regard to subjects affected by alopecia) do not define the teachings: “Applicants erroneously point to specific embodiments expressly disclosed within the prior art reference as representing the sum total of information conveyed by each. Art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989).” Therefore, based on Goren’s claim scope that addresses a broad subject population, and more specifically the exact skin surface possessing hair follicles required by applicant, the instant method of applying midodrine compositions to human scalps generally, and the hair structures upon them is obvious (see hair cross section image below).
Furthermore, Applicant has not specified a patient population that differentiates from Goren’s claim 1 subject population. The condition of instant claim 31 (i.e., “that regulates activity of genes and/or proteins in cells of the hair follicles and changing hair phenotype as hair fiber is actively produced at bulbs of the hair follicles and grows out of the skin”) does not differentiate the instant invention from Goren, because Goren’s method of applying midodrine compositions to the hair and/or scalp is expected to provide the same effect to the hair fiber, as a result of the active steps of Goren’s method that applies composition comprising midodrine to the scalp having hair (Goren – claims 1, 14 and 43-44).
On page 11, Applicant argues a different target of delivery, whereas the instant method targets the follicular bulb of hair (i.e., Applicant claims by contrast Goren targets the arrector pili). Note, that both the instant claim scope limitations and Goren both teach a method that applies midodrine compositions to the scalp (Goren – claim 1) (which by definition contains hair follicles, hair fibers, arrector pili, follicular bulb of hair, etc., see below). Thus, by this logic, both the instant method and Goren’s method actively apply composition to same targets on the scalp (i.e., the follicular bulb and arrector pili are both structures of the scalp and/or hair), in spite of the claimed difference of mechanisms. Lumen Learning (2016) provides a diagram that demonstrates the proximity of the hair bulb (aka, follicular bulb) to the arrector pili muscle (pg 3; see below), whereby Goren’s application of the midodrine composition to scalp would affect both purported targets.
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On page 11, Applicant argues that the narrowing of claim 32 that applies only to hair straightening by midodrine, further represents non-obviousness of the claim method. However, as discussed before, Goren teaches the obviousness of the instant method of applying midodrine compositions in the instant amounts described by Applicant to the hair and/or scalp, and the discovered hair straightening effect is expected to be a property of Goren’s compositions, and the hair straightening properties would necessarily flow from the topical application of midodrine salt compositions described by Goren, owing to the fact that the active agent and method steps suggested by the art and recited in the present claims are the same. Applicant has not provided objective evidence that Goren’s compositions would not be capable of straightening hair in contrast to the instant Application. Additionally, as discussed before, Goren teaches flat ironing the hair (i.e., where That’s Foxy teaches flat ironing as a method of styling/straightening hair), where the improved straightening effect would be expected from application of midodrine.
On page 11-12, Applicant argues that Goren teaches (1) midodrine “about 58 other possible agents” and (2) that “midodrine salt” is not disclosed specifically.
With respect to point (1), note that in terms of obviousness, it is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985). Thus, a method of applying a midodrine composition to the scalp and/or hair is obvious, based on the teachings of Goren.
With respect to point (2), the Examiner points to the section of Goren that includes all salt forms of the active agent agonists [0089], including the alpha adrenergic receptor agonists, such as midodrine [0049, 0084]. Also, Goren provides examples of salt forms as TAAR agonist active agents [0049], thus rendering midodrine salt as suitable active agent from the perspective a PHOSITA, because salt forms of topical active agents are demonstrated to have the intended biological activity. Finally, Applicant has provided no objective evidence that the salt form of midodrine salt would provide no suitable biological activity in Goren’s disclosure.
On page 12, Applicant argues that Hermann does not resolve the issues of Goren. However, the teachings of Goren are still used to maintain rejection of the instant claim set. Hermann is only provided teach ancillary elements of the claim set (e.g., specific thickeners such as xanthan gum (instant claim 46), and specific alcohols such as glycerin (instant claim 48)), as described int the 103 rejection, whereby Hermann is reasonably analogous to the instant invention subject matter).
On page 13, Applicant concludes. However, the claims remain under rejection by 103.
Correspondence
Applicant's amendment necessitated the new ground of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/R.P./Examiner, Art Unit 1614 5/14/26
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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